The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Creighton University
Study ID
NCT00657891
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
  • Placebo — DRUG
    Placebo Injection

Study Details

We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Key Dates

Start date
Mar 31, 2007
Status verified
Sep 2013
Primary completion
Oct 31, 2007
Completion
Oct 31, 2007

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: 1
    Placebo Injection
  • Experimental: 2
    Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

Primary Outcome Measure

To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore. [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Creighton University Medical CenterOmahaNebraska68131-

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